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U.S. Department of Health and Human Services

Class 2 Device Recall Bravo pH capsule delivery device

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  Class 2 Device Recall Bravo pH capsule delivery device see related information
Date Initiated by Firm April 15, 2016
Date Posted May 06, 2016
Recall Status1 Terminated 3 on July 13, 2017
Recall Number Z-1619-2016
Recall Event ID 73882
510(K)Number K002028  
Product Classification Electrode, ph, stomach - Product Code FFT
Product Given Imaging Bravo¿ pH capsule delivery device, 5-pack.
In-Vitro Diagnostic for pH monitoring of gastric reflux
Item Number: FGS-0312

The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Potential of an allergic reaction in a patient with nickel sensitivity.
FDA Determined
Cause 2		 Device Design
Action The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/2016 to its Customers via Federal Express. The letter describes the product, problem and actions to be taken.The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance MITGFCA@Covidien.com or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo¿ pH monitoring system User Manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. "The Bravo capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. The Bravo¿ pH test lasts from 48-96 hours." If you have any questions, please contact Technical Service at 1-800-448-3644, option 3.
Quantity in Commerce 12,895 units
Distribution Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FFT and Original Applicant = ENDONETICS, INC.
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